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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

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Pediatric Labeling Date:  12/21/2005
 
Trade Name:  Fosamax
 
Generic Name or Proper Name (*):  alendronate
 
Indications Studied:  Severe osteogenesis imperfecta
 
Label Changes Summary:  * Alendronate is not indicated for use in children * The efficacy and safety were examined in a randomized, double-blind, placebo-controlled two-year study of 139 patients, 4-18 years old, with severe osteogenesis imperfecta * Treatment with alendronate did not reduce the risk of fracture * There were no statistically significant differences between the alendronate and placebo groups in reduction of bone pain * Information on PK parameters, AE profile, and clinical studies
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Merck
 
Pediatric Exclusivity Granted Date:  04/28/2003
 
NNPS:  FALSE
 
Therapeutic Category:  Bone density
 
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